MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX ESOPHAGEAL; PROSTHESIS, ESOPHAGEAL

Model Number M00516750

Device Problem Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/07/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation on september 29, 2018 that a wallflex esophageal fully covered stent was to be used to treat a malignant stricture due to esophageal cancer during an endoscopic retrograde cholangiopancreatography (ercp) with esophageal stent placement procedure performed on (b)(6) 2018.Reportedly, the patient's anatomy was not tight and was not dilated prior to stent placement.According to the complainant, during the procedure, the stent fell into the stomach right after it was deployed in the esophagus.The stent was removed with forceps and another wallflex esophageal stent was placed to complete the procedure.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.

Manufacturer Narrative

H6: problem code 3009 captures the reportable event of stent positioning/ placement problem.H10: a deployed wallflex esophageal fully covered stent and delivery system were returned for analysis.The stent was received fully expanded.Visual examination of the returned device identified no issues with the stent and delivery system.The stent was measured to be within specifications.The investigation concluded that procedural factors such as the handling of the device and normal procedural difficulties encountered during the procedure could have affected the device performance contributing to the reported event.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly, and performance specifications at the time of release for distribution.This supplemental correction report is being filed to correct the report number in a previously submitted supplemental report (follow-up number 001) which was accepted by fda on 12/14/2018 03:28 pm ct.The report number is being corrected from: 3005099803-2018-61982 to: 3005099803-2018-60991.

Event Description

It was reported to boston scientific corporation on september 29, 2018 that a wallflex esophageal fully covered stent was to be used to treat a malignant stricture due to esophageal cancer during an endoscopic retrograde cholangiopancreatography (ercp) with esophageal stent placement procedure performed on (b)(6) 2018.Reportedly, the patient's anatomy was not tight and was not dilated prior to stent placement.According to the complainant, during the procedure, the stent fell into the stomach right after it was deployed in the esophagus.The stent was removed with forceps and another wallflex esophageal stent was placed to complete the procedure.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.

• Brand Name: WALLFLEX ESOPHAGEAL
• Type of Device: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8004990
• MDR Text Key: 124997870
• Report Number: 3005099803-2018-60991
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729778080
• UDI-Public: 08714729778080
• Combination Product (y/n): N
• PMA/PMN Number: K091510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/19/2018
• Device Model Number: M00516750
• Device Catalogue Number: 1675
• Device Lot Number: 0020176288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2018
• Date Manufacturer Received: 11/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention